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Course Description

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.
One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
Why you should attend
This 6 hrs. webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.
Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.
Learning Objectives:
The Medical Device Single Audit Program (MDSAP)
Device Classification
Licensing Pathways
Medical Device GMP
Inspections
Device Labeling
License Holder Responsibilities
Timelines and Fees
Country Specific Cultural Considerations and Challenges
Adverse Event ReportingCourse Audience:

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There are no upcoming events listed for this course. Feel free to contact us, chat or call 1-866-540-9677 for additional info. In the mean time please Search for additional courses or view similar courses below.